The Medicines Company Wins Favorable Judgment in Angiomax® (Bivalirudin) Patent Litigation
The Medicines Company (NASDAQ:MDCO) announced the U.S. District Court for the Northern District of Illinois in The Medicines Company v. Mylan, Inc. entered judgment in favor of The Medicines Company on all issues concerning U.S. Patent No. 7,582,727 (the “’727 patent”). Following a June 2014 trial, Judge Amy St. Eve found all of the asserted claims (patent claims 1-3, 7-10, and 17) are infringed by Mylan’s Abbreviated New Drug Application (“ANDA”). The same claims were also found to be valid and enforceable.
“We are highly satisfied with the Illinois Court’s ruling, which supports our ongoing conviction to defend these patents vigorously,” said Clive Meanwell, Chairman and Chief Executive Officer for The Medicines Company.
Mylan’s ANDA seeks FDA approval to commercially manufacture, use or sell a generic version of The Medicines Company’s Angiomax® (bivalirudin) drug product before the expiration of the ’727 patent. The ruling prevents Mylan from obtaining FDA approval of its generic bivalirudin and launching its ANDA product until the earlier of a successful appeal or expiration of the ’727 patent in 2028. To appeal successfully, Mylan must overturn the Court’s rulings on each of the asserted claims.
About The Medicines Company
The Medicines Company's purpose is to save lives, alleviate suffering and contribute to the economics of healthcare by focusing on 3000 leading acute/intensive care hospitals worldwide. Its vision is to be a leading provider of solutions in three areas: serious infectious disease care, acute cardiovascular care, and surgery and perioperative care. The company operates in the Americas, Europe and the Middle East, and Asia Pacific regions with global centers today in Parsippany, NJ, USA and Zurich, Switzerland.
Statements contained in this press release about The Medicines Company that are not purely historical, and all other statements that are not purely historical, may be deemed to be forward-looking statements for purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995. Without limiting the foregoing, the words "believes," "anticipates" "expects" and “potential” and similar expressions, are intended to identify forward-looking statements. These forward-looking statements involve known and unknown risks and uncertainties that may cause the Company's actual results, levels of activity, performance or achievements to be materially different from those expressed or implied by these forward-looking statements. Important factors that may cause or contribute to such differences include whether the Company is able to maintain its market exclusivity for Angiomax in the United States by enforcing its U.S. patents covering Angiomax and such other factors as are set forth in the risk factors detailed from time to time in the Company's periodic reports and registration statements filed with the Securities and Exchange Commission including, without limitation, the risk factors detailed in the Company's Quarterly Report on Form 10-Q filed with the SEC on August 4, 2014, which are incorporated herein by reference. The Company specifically disclaims any obligation to update these forward-looking statements.
The Medicines Company
Bob Laverty, +1-973-290-6162
Mobile: +1 609-558-5570
Vice President, Communications
Office of D.E.S.I.G.N.
Investor Relations, +1-973-290-6044